Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06356766

Investigation of Effectiveness of Telerehabilitation for Zone 2 Flexor Tendon Injuries of the Hand

The treatment process following Zone 2 flexor tendon injuries, which are particularly controversial for hand surgery, is challenging. There are various rehabilitation methods for Zone 2 flexor tendon injuries, one of which is the Modified Duran Protocol. Disruptions in the physiotherapy process lead to joint contractures, tendon adhesions, and limitations in daily life activities for patients. Due to global issues such as socioeconomic factors, physical barriers, distance, and pandemics, patients who cannot actively participate in physiotherapy miss out on the rehabilitation process.

The aim of the present study is to investigate the effectiveness of the Modified Duran protocol applied through telerehabilitation following Zone 2 flexor tendon repair. Between April and October 2024, a total of 42 adults aged 18-55 who underwent Zone 2 flexor tendon repair at Istanbul University Istanbul Faculty of Medicine will be recruited, with 21 participants in face-to-face clinic group and 21 in telerehabilitation group. Rehabilitation process will be followed for 12 weeks. The telerehabilitation group will receive exercise training on the third day. After the first training session, patients will be discharged and called to the clinic once a week for dressing changes, monitoring, exercises and if necessary, revision of the protective splint. Patients will be contacted three times a week to implement the planned program using telerehabilitation.

The face-to-face rehabilitation group will receive face-to-face clinic rehabilitation three times a week under the supervision of a physiotherapist for the first 12 weeks.

Patients will be evaluated at the end of the 5th, 6th, and 12th weeks. Data collection tools will include a 'Sociodemographic Form', 'Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire', 'Visual Analog Scale (VAS)', 'Jamar Hand Dynamometer', and 'Goniometer (Joint Range of Motion)'.

SPSS (Statistical Package for the Social Sciences) Statistics will be used for the statistical analysis of all data, with a significance level of p <0.05 considered significant in all assessments, and accepted as two-tailed.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals with isolated Zone 2 flexor digitorum profundus (FDP) and flexor digitorum superficialis (FDS) injuries,
  • Repair performed within the first 72 hours post-injury,
  • Individuals aged between 18 and 55 years,
  • Patients willing to participate in the study,
  • Ability to attend sessions regularly.

Exclusion criteria

  • Fingers with concomitant fractures, digital nerve injuries, vascular injuries, or significant skin loss accompanying flexor tendon injuries,
  • Bilateral flexor tendon injuries,
  • Patients with replantation or revascularization,
  • Flexor Pollicis Longus tendon injuries of the thumb due to differences in protocols applied and measurement of final outcomes,
  • Patients unable to understand and perform postoperative exercises

Treatment and study plan

telerehabilitation

Other

Modified Duran Protocol via Telerehabilitation

Face-to-Face Rehabilitation

Other

Modified Duran Protocol

Primary outcomes

  1. Range of Motion

    Time frame: First week, 5th week, 6th week, 12th week

    Modified Strickland Formula

Secondary outcomes

  1. DASH

    Time frame: First week, 5th week, 6th week, 12th week

    Disabilities of the Arm, Shoulder and Hand; min: 0 max: 100, lower scores indicate a lower level of disability

  2. Pain of the affected hand

    Time frame: First week, 5th week, 6th week, 12th week

    Visual Analogue Scale, min:0 cm/mm, max: 10 cm/100 mm, higher scores mean a higher degree of pain

  3. Muscle Strength

    Time frame: 12th week

    Jamar Hydraulic Hand Dynamometer

Study contacts

Contact information is provided by the study sponsor or research team.

Fatma M Akpınar

CONTACT

[email protected]

+905333558843

Sema Güven

CONTACT

[email protected]

+905077531403

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

Investigation of Effectiveness of Modified Duran Protocol Via Telerehabilitation After Zone 2 Flexor Tendon Injury Repair of the Hand

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Apr 10, 2024
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.